Zuclopenthixol dihydrochloride for schizophrenia

Edward J Bryan; Marie Ann Purcell; Ajit Kumar

doi:10.1002/14651858.CD005474.pub2

Scolaris Content Display Scolaris Content Display

Figure 1

Study flow diagram ‐ update 2016.

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Analysis 1.1

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 1 Leaving the study early (any reason).

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Analysis 1.2

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 2 Adverse effects: 1. Clinically important change in specific adverse effects ‐ cardiovascular ‐ orthostatic.

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Analysis 1.3

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 3 Adverse effects: 2. Clinically important change in specific adverse effects ‐ central nervous system ‐ arousal state.

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Analysis 1.4

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 4 Adverse effects: 3. Clinically important change in specific adverse effects ‐ endocrine ‐ menstruation started.

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Analysis 1.5

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 5 Adverse effects: 4a. Any general adverse effects ‐ movement disorders ‐ EPSEs (UKU side effect rating scale, no scores).

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Analysis 1.6

Comparison 1 ZUCLOPENTHIXOL versus PLACEBO ‐ all short term, Outcome 6 Adverse effects: 4b. Clinically important change in specific adverse effects ‐ movement disorders ‐ EPSEs.

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Analysis 2.1

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI, scores not reported).

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Analysis 2.2

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 2 Global state: 2. Average endpoint global state score ‐ No Recovery.

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Analysis 2.3

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 3 Global state: 3a. Average endpoint global state score (GAS, high score not reported, average score = 63.4).

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Analysis 2.4

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 4 Global state: 3b. Average endpoint global state score (CGI‐SI, high score not reported, average score = 2.2).

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Analysis 2.5

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 5 Mental state: 1. No clinically important change in general mental state ‐ Not improved (PANSS, scores not reported).

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Analysis 2.6

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 6 Mental state: 2. No clinically important change in general mental state ‐ No clinical response.

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Analysis 2.7

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 7 Mental state: 3. Average endpoint general mental state score (BPRS, high score = 34.2).

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Analysis 2.8

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 8 Leaving the study early (any reason).

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Analysis 2.9

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 9 Adverse effects: 1. Any general adverse effects ‐ side effects (CGI, high score not reported).

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Analysis 2.10

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 10 Adverse effects: 2. Average endpoint general adverse effect score ‐ average score (TESS, high score not reported, average score = 12.00).

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Analysis 2.11

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 11 Adverse effects: 3. Any change in specific adverse effects ‐ cardiovascular ‐ postural hypotension (dizziness/syncope).

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Analysis 2.12

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 12 Adverse effects: 4. Any change in specific adverse effects ‐ central nervous system ‐ arousal.

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Analysis 2.13

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 13 Adverse effects: 5. Any change in specific adverse effects ‐ metabolic ‐ weight change ‐ loss or gain of weight of 10 pounds.

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Analysis 2.14

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 14 Adverse effects: 6a. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs.

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Study	Zuclopenthixol	Chlorpromazine
Kingstone 1970	n = 5, authors do not state which additional medication.	n = 2, authors do not state which additional medication.
Kordas 1968	Benzhexol and diazepam if necessary.	Benzhexol and diazepam if necessary.
Wang 1995a	Trihexphenidyl or scopolamine used if necessary. Authors do not report frequency of use or which group used which.	Trihexphenidyl or scopolamine used if necessary. Authors do not report frequency of use or which group used which.

Analysis 2.15

Comparison 2 ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term, Outcome 15 Adverse effects: 6b. Any change in specific adverse effects ‐ movement disorders ‐ additional medication use.

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Analysis 3.1

Comparison 3 ZUCLOPENTHIXOL versus CHLORPROTHIXENE ‐ all medium term, Outcome 1 Global state: Average endpoint global state score ‐ Unchanged/worse (CGI).

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Analysis 3.2

Comparison 3 ZUCLOPENTHIXOL versus CHLORPROTHIXENE ‐ all medium term, Outcome 2 Leaving the study early (any reason).

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Analysis 4.1

Comparison 4 ZUCLOPENTHIXOL versus CLOZAPINE ‐ all short term, Outcome 1 Leaving the study early (any reason).

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Study	Zuclopenthixol (n = 36)	Clozapine (n = 38)
Fischer‐Cornelssen 1976	Drowsiness (12%); Stimulation (14%); Confusion (1%); GI (1%); anticholinergic (14%); dizziness (6%); Orthostatic reaction (1%); Headache (2%); Hypersalivation (2%); hypokinesia (4%); hyperkinesia (2%); dyskinesia (0.4%); rigor (5%); tremor (5%); akathisia (3%)	Drowsiness (12%); Stimulation (21%); Confusion (3%); GI (8%); anticholinergic (8%); dizziness (15%); Orthostatic reaction (6%); Headache (3%); Hypersalivation (4%); hypokinesia (2%); hyperkinesia (4%); dyskinesia (0%); rigor (1%); tremor (3%); akathisia (3%)

Analysis 4.2

Comparison 4 ZUCLOPENTHIXOL versus CLOZAPINE ‐ all short term, Outcome 2 Adverse effects: Any general adverse effects ‐ side effects ‐ frequency per day.

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Analysis 5.1

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI).

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Analysis 5.2

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 2 Global state: 2. Average endpoint global state score (CGI, mean score = 1.25).

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Analysis 5.3

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 3 Leaving the study early (any reason).

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Analysis 5.4

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 4 Adverse effects: 1. Any change in specific adverse effects ‐ interference with functioning.

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Analysis 5.5

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 5 Adverse effects: 2. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication.

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Analysis 5.6

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 6 Adverse effects: 3. Any change in specific adverse effects ‐ requiring additional medication.

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Analysis 5.7

Comparison 5 ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term, Outcome 7 Adverse effects: 4. Any change in specific adverse effects ‐ requiring hypnotics/sedatives.

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Analysis 6.1

Comparison 6 ZUCLOPENTHIXOL versus PERPHENAZINE, Outcome 1 Global state: Average endpoint global state score ‐ unchanged/worse (global rating ‐ investigator opinion) ‐ medium term.

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Analysis 6.2

Comparison 6 ZUCLOPENTHIXOL versus PERPHENAZINE, Outcome 2 Leaving the study early (any reason) ‐ short/medium term.

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Analysis 6.3

Comparison 6 ZUCLOPENTHIXOL versus PERPHENAZINE, Outcome 3 Adverse effects: 1. Any change in specific adverse effects ‐ central nervous system ‐ arousal ‐ requiring medication ‐ medium term.

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Analysis 6.4

Comparison 6 ZUCLOPENTHIXOL versus PERPHENAZINE, Outcome 4 Adverse effects: 2. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication ‐ medium term.

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Analysis 7.1

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 1 Mental State: 1. Average endpoint general mental state score (PANSS, average score = 45.8) ‐ medium term.

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Analysis 7.2

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 2 Mental State: 2. Average endpoint general mental state score (PANSS General, average score medium term = 20.5) ‐ short/medium term.

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Analysis 7.3

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 3 Mental State: 3. Average endpoint general mental state score (PANSS Positive, average score = 9.8) ‐ medium term.

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Analysis 7.4

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 4 Mental State: 4. Average endpoint general mental state score (PANSS Negative, average score 11.5) ‐ medium term.

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Analysis 7.5

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 5 Leaving the study early (any reason) ‐ short/medium term.

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Study	Zuclopenthixol	Risperidone
Fagerlund 2004	Benzodiazepines n = 7 Anticholinergics n = 11	Benzodiazepines n = 8 Anticholinergics n = 7
Glenthoj 2007	Anticholinergic n = 10, Benzodiazepines n = 11, Antidepressant n = 1	Authors do not differentiate the use of additional medication between the two groups, totals only given.

Analysis 7.6

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 6 Adverse Effects: 1. Any change in general adverse effects ‐ additional medication use ‐ short/medium term.

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Analysis 7.7

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 7 Adverse effects: 2a. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication ‐ short term.

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Analysis 7.8

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 8 Adverse Effects: 2b. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs (ESRS) ‐ short term.

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Analysis 7.9

Comparison 7 ZUCLOPENTHIXOL versus RISPERIDONE, Outcome 9 Adverse effects: 3. Any change in specific adverse effects ‐ negative and cognitive symptoms of schizophrenia ‐ short term.

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Analysis 8.1

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI).

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Analysis 8.2

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 2 Global State: 2. Average endpoint global state score ‐ Moderately or severely ill (CGI).

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Analysis 8.3

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 3 Mental State: Average endpoint general mental state score (BPRS, average = 5.7).

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Analysis 8.4

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 4 Leaving the study early (any reason).

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Study	Zuclopenthixol	Sulpiride
Mahadevan 1991	n = 4 Amitriptyline	n = 4 Amitryptyline

Analysis 8.5

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 5 Adverse Effects: 1. Any change in general adverse effects ‐ additional medication use.

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Analysis 8.6

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 6 Adverse Effects: 2. Any change in specific adverse effects ‐ metabolic ‐ weight change.

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Analysis 8.7

Comparison 8 ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term, Outcome 7 Adverse effects: 3. Any change in specific adverse effects ‐ requiring additional medication ‐ hypnotics/sedatives.

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Analysis 9.1

Comparison 9 ZUCLOPENTHIXOL versus THIOTHIXENE ‐ all medium term, Outcome 1 Global state: Average endpoint global state score ‐ unchanged/worse (CGI).

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Analysis 9.2

Comparison 9 ZUCLOPENTHIXOL versus THIOTHIXENE ‐ all medium term, Outcome 2 Leaving the study early (any reason).

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Analysis 10.1

Comparison 10 ZUCLOPENTHIXOL versus TRIFLUOPERAZINE ‐ all short term, Outcome 1 Leaving the study early (any reason).

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Analysis 11.1

Comparison 11 ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term, Outcome 1 Leaving the study early (any reason).

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Analysis 11.2

Comparison 11 ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term, Outcome 2 Behaviour: Average change in specific aspects of behaviour ‐ Violence during follow‐up.

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Study

Zuclopenthixol

Depot

Arango 2006

n = 1 Propanolol

n = 1 venlafaxine

n = 1 Lithium

Analysis 11.3

Comparison 11 ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term, Outcome 3 Adverse Effects: 1a. Any general adverse effects ‐ additional medication use.

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Analysis 11.4

Comparison 11 ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term, Outcome 4 Adverse Effects: 1b. Any change in specific adverse effects ‐ additional medication use ‐ benzodiazepine use at least once.

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Analysis 12.1

Comparison 12 CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term, Outcome 1 Global state: Average endpoint global state score ‐ Unwell.

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Analysis 12.2

Comparison 12 CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term, Outcome 2 Mental state: Average endpoint general mental state score ‐ Not improved.

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Analysis 12.3

Comparison 12 CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term, Outcome 3 Leaving the study early (any reason).

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Analysis 12.4

Comparison 12 CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term, Outcome 4 Adverse Effects: 1a. Any general adverse effects ‐ side effects reported.

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Study	Cis Z	Cis(Z)/Trans(E)
Gravem 1981	EPSEs most frequent. Authors state no significant difference between two isomers.	EPSEs most frequent.
Heikkila 1981	Dry mouth, Disturbance of accommodation, Disturbance of urination, Constipation, Dizziness, Headache, Increased sweating, Drowsiness, Anxiety, Parkinsonism, Akathisia, Tardive dyskinesia and others	Dry mouth, Disturbance of urination, Constipation, Dizziness, Drowsiness, Parkinsonism, Akathisia, Tardive dyskinesia, others

Analysis 12.5

Comparison 12 CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term, Outcome 5 Adverse Effects: 1b. Any change in specific adverse effects ‐ individual side effects.

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Summary of findings for the main comparison. Zuclopenthixol dihydrochloride versus placebo

Patient or population: people with schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: PLACEBO (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with PLACEBO (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Adverse effects: Clinically important general adverse effect (extrapyramidal effects ‐ UKU side effect rating scale)	80 per 1000	486 per 1000 (69 to 1000)	RR 6.07 (0.86 to 43.04)	28 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2, 3,4, 5, 6}	Risk assumed to be moderate and rounded from 7.69% to 8%.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: Duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Leaving the study early (any reason)	40 per 1000	12 per 1000 (0 to 264)	RR 0.29 (0.01 to 6.60)	100 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1, 6}	Risk assumed to be moderate and rounded from 3.85% to 4%. Low number of events in both RCTs.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated 'very serious' ‐ possible selection bias, blinding may have been single, attrition bias and reporting bias. ² Risk of bias: rated 'very serious' ‐ selection, attrition and reporting bias ³ Risk of inconsistency: rated 'not serious' ‐ suspected but not found. ⁴ Risk of publication bias: rated 'strongly suspected' ‐ multiple papers published with the same patient cohort. ⁵ Risk of large effect: rated 'very large' ‐ RR 6.07, small n number but result likely when versus placebo. ⁶ Risk of imprecision: rated 'very serious' ‐ low n numbers

Summary of findings for the main comparison. Zuclopenthixol dihydrochloride versus placebo

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Summary of findings 2. Zuclopenthixol dihydrochloride versus chlorpromazine

Patient or population: schizophrenia Setting: Outpatient and inpatient (predominantly hospitalised) Intervention: ZUCLOPENTHIXOL Comparison: CHLORPROMAZINE (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with CHLORPROMAZINE (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (CGI‐SI, high score not reported, average score = 2.2)		The mean CGI‐SI endpoint score in the intervention group (MD) was 0 (‐0.49 lower to 0.49 higher)	‐	64 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 5}	Translated study.
Adverse effects: Clinically important general adverse effect (EPSEs)	300 per 1000	282 per 1000 (183 to 435)	RR 0.94 (0.61 to 1.45)	199 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{2 4 5 6}	Risk control rounded to 30% and set to moderate. Mixture of inpatient and outpatient, though predominantly hospitalised patients.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (BPRS, high score = 34.2)		The mean mental state: average endpoint score (BPRS, high score = 34.2) in the intervention group was 0.4 more (2.43 fewer to 3.23 more)	‐	221 (3 RCTs)	⊕⊕⊝⊝ LOW ^{2 6}	Mixture of inpatient and outpatient, though predominantly hospitalised patients.
Leaving the study early (any reason)	70 per 1000	38 per 1000 (25 to 57)	RR 0.54 (0.36 to 0.81)	766 (6 RCTs)	⊕⊕⊝⊝ LOW ^{3 6}	Mixture of inpatient and outpatient, though predominantly hospitalised patients. Risk control set to moderate and rounded to 7%; extreme values not likely.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated 'serious' ‐ Selection and attrition bias likely. ² Risk of bias: rated 'serious' ‐ Selection attrition bias. ³ Risk of bias: rated 'serious' ‐ Selection, attrition and reporting bias. ⁴ Risk of bias: rated 'serious' ‐ Selection, attrition and reporting bias. Risk of inconsistency: rated as 'serious' ‐ All three papers reported on differing population sizes and obtained different levels of EPSEs in the experimental and control groups. ⁵ Risk of imprecision: rated 'very serious' ‐ low n numbers ⁶ Risk of indirectness: rated 'very serious' ‐ mixed samples For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 2. Zuclopenthixol dihydrochloride versus chlorpromazine

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Summary of findings 3. Zuclopenthixol dihydrochloride versus chlorprothixene

Patient or population: schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: CHLORPROTHIXENE (medium term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with CHLORPROTHIXENE (medium term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Leaving the study early (any reason)	400 per 1000	400 per 1000 (136 to 1000)	RR 1.00 (0.34 to 2.93)	20 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ selection, reporting bias likely. ² Risk of publication bias: rated as 'strongly suspected' ‐ several papers published using the same cohort of patients. ³ Risk of imprecision: rated 'very serious' ‐ low n numbers For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 3. Zuclopenthixol dihydrochloride versus chlorprothixene

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Summary of findings 4. Zuclopenthixol dihydrochloride versus clozapine

Patient or population: schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: CLOZAPINE (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with CLOZAPINE (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Leaving the study early (any reason)	0 per 1000	0 per 1000 (0 to 0)	not estimable	407 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2}	Multi‐centre, multi‐drug trial with disproportionate numbers of people in different arms of the study. The authors did not report that anybody left the study in the Zuclopenthixol and clozapine arms.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ selection, attrition, reporting and performance bias likely. ² Risk of indirectness: rated 'serious' ‐ Multiple study arms For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 4. Zuclopenthixol dihydrochloride versus clozapine

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Summary of findings 5. Zuclopenthixol dihydrochloride versus haloperidol

Patient or population: schizophrenia Setting: Hospital only. Intervention: ZUCLOPENTHIXOL Comparison: HALOPERIDOL (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with HALOPERIDOL (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (CGI, mean score = 1.25)		The mean CGI endpoint score in the intervention group (MD) was 0.13 more (‐0.3 fewer to 0.55 more)	‐	49 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 3 4}	Small study, multiple scales used (NOSIE30, BPRS, CGI). Paper only reported outcomes of some of these scales.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Leaving the study early (any reason)	300 per 1000	297 per 1000 (216 to 405)	RR 0.99 (0.72 to 1.35)	141 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 4}	Risk control rounded to 30% from 29.25% and, as extreme values unlikely, it was set to moderate.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'very serious' ‐ likely selection, attrition, reporting and diagnostic purity bias. ² Risk of bias: rated as 'serious' ‐ likely selection, attrition, reporting and diagnostic purity bias. Risk of inconsistency: rated as 'serious' ‐ both papers generated differing values for people leaving the study and do not appear consistent (face validity). ³ Risk of imprecision: rated 'serious' ‐ low n numbers ⁴ Risk of indirectness: rated 'serious' ‐ not all scales reported For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 5. Zuclopenthixol dihydrochloride versus haloperidol

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Summary of findings 6. Zuclopenthixol dihydrochloride versus perphenazine

Patient or population: schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: PERPHENAZINE (short and medium term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with PERPHENAZINE (short and medium term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Adverse effects: Clinically important general adverse effect (EPSEs requiring medication ‐ medium term)	400 per 1000	760 per 1000 (448 to 1000)	RR 1.90 (1.12 to 3.22)	50 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Leaving the study early (any reason, short and medium term)	207 per 1000	130 per 1000 (56 to 304)	RR 0.63 (0.27 to 1.47)	104 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ likely selection and reporting bias. ² Risk of imprecision: rated 'very serious' ‐ low n numbers For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 6. Zuclopenthixol dihydrochloride versus perphenazine

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Summary of findings 7. Zuclopenthixol dihydrochloride versus risperidone

Patient or population: schizophrenia Setting: Mostly hospital. Huttunen group did not state Intervention: ZUCLOPENTHIXOL Comparison: RISPERIDONE (short and medium term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with RISPERIDONE (short and medium term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Adverse effects: Clinically important general adverse effect ‐ short term (EPSEs requiring medication)	271 per 1000	520 per 1000 (303 to 888)	RR 1.92 (1.12 to 3.28)	98 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 5 6}
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (PANSS, average score = 20.5) ‐ medium term		The mean PANNS endpoint score in the intervention group (MD) was 3.2 fewer (‐7.71 fewer to 1.31 more)	‐	25 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}	Small study. Standard deviations may be standard errors. Open label trial.
Leaving the study early (any reason, short and medium term)	310 per 1000	403 per 1000 (260 to 626)	RR 1.30 (0.84 to 2.02)	154 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^{3 4}	Risk control taken as mean of extremes: high + low / 2 (changed from 21.43% to 31%)
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'very serious' ‐ open label trial, likely selection bias. ² Risk of imprecision: rated as 'very serious' ‐ strongly suspect reported standard deviations are standard errors, low n numbers ³ Risk of publication bias: rated as 'strongly suspected' ‐ all studies published findings across several consecutive years in different journals and at conferences. ⁴ Risk of bias: rated as 'very serious' ‐ study 1 (selection, reporting, diagnostic purity and attrition bias likely ‐ author emailed); study 2 (open label); study 3 (reporting and attrition bias). ⁵ Risk of publication bias: rated as 'strongly suspected' ‐ multiple papers over consecutive years published with the same data. ⁶ Risk of bias: rated as 'serious' ‐ diagnostic purity and attrition bias; likely selection and reporting bias (authors contacted) For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 7. Zuclopenthixol dihydrochloride versus risperidone

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Summary of findings 8. Zuclopenthixol dihydrochloride versus sulpiride

Patient or population: schizophrenia Setting: Not specified in study. Intervention: ZUCLOPENTHIXOL Comparison: SULPIRIDE (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with SULPIRIDE (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (CGI ‐ unchanged/worse)	226 per 1000	266 per 1000 (111 to 644)	RR 1.18 (0.49 to 2.85)	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	The study did not report clinical improvement so unchanged/worse is reported for this outcome. Usually we report clinical improvement.
Adverse effects: Clinically important general adverse effect ‐ requiring hypnotics/sedatives	419 per 1000	252 per 1000 (113 to 554)	RR 0.60 (0.27 to 1.32)	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (BPRS)		The mean BPRS endpoint score in the intervention group (MD) was 1.3 fewer (‐5.08 fewer to 2.48 more)	‐	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}
Leaving the study early (any reason)	230 per 1000	476 per 1000 (223 to 1000)	RR 2.07 (0.97 to 4.40)	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	Control of risk rounded up from 22.58% to 23%.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ diagnostic purity, attrition bias. Per‐Protocol analysis suspected. ² Risk of imprecision: rated as ' very serious' ‐ percentages used to describe data and comparisons are made against an assumption of baseline measurements. Low n numbers. For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 8. Zuclopenthixol dihydrochloride versus sulpiride

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Summary of findings 9. Zuclopenthixol dihydrochloride versus thiothixene

Patient or population: schizophrenia Setting: hospital Intervention: ZUCLOPENTHIXOL Comparison: THIOTHIXENE (medium term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with THIOTHIXENE (medium term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (unchanged/worse ‐ CGI)	600 per 1000	300 per 1000 (102 to 876)	RR 0.50 (0.17 to 1.46)	20 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}	The study did not report clinical improvement so unchanged/worse is reported for this outcome. Usually we report clinical improvement.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported on this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported on this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported on this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported on this outcome.
Leaving the study early (any reason)	700 per 1000	399 per 1000 (168 to 945)	RR 0.57 (0.24 to 1.35)	20 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No studies reported on this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ likely selection and reporting bias. ² Risk of publication bias: rated as 'strongly suspected' ‐ several papers published using the same cohort. ³ Risk of imprecision: rated as 'serious' ‐ low n numbers For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 9. Zuclopenthixol dihydrochloride versus thiothixene

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Summary of findings 10. Zuclopenthixol dihydrochloride versus trifluoperazine

Patient or population: schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: TRIFLUOPERAZINE (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with TRIFLUOPERAZINE (short term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Leaving the study early (any reason)	0 per 1000	0 per 1000 (0 to 0)	not estimable	72 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}	Multi‐centre and multi‐drug trial with low numbers in each arm.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ selection, attrition, reporting and performance bias likely. ² Risk of imprecision: rated 'very serious' ‐ low n numbers ³ Risk of indirectness: rated 'very serious' ‐ multiple arms, some missing For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 10. Zuclopenthixol dihydrochloride versus trifluoperazine

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Summary of findings 11. Zuclopenthixol dihydrochloride versus zuclopenthixol depot

Patient or population: schizophrenia Setting: Hospital Intervention: ZUCLOPENTHIXOL Comparison: ZUCLOPENTHIXOL DEPOT (long term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with ZUCLOPENTHIXOL DEPOT (long term)	Risk with ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Adverse effects: Clinically important general adverse effect (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Leaving the study early (any reason)	80 per 1000	156 per 1000 (29 to 846)	RR 1.95 (0.36 to 10.58)	46 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3}	Control of risk rounded from 7.69% to 8%.
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'very serious' ‐ single researcher did randomisation, selection bias likely, open label trial and incomplete outcome data. ² Risk of publication bias: rated as 'strongly suspected' ‐ several papers published using the same data and cohort. ³ Risk of imprecision: rated 'very serious' ‐ low n numbers For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 11. Zuclopenthixol dihydrochloride versus zuclopenthixol depot

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Summary of findings 12. Zuclopenthixol dihydrochloride (Cis Z isomer) versus Zuclopenthixol (Cis Z/Trans E isomer)

Patient or population: schizophrenia Setting: Mostly inpatient. 4 Studies included of which two did not state but implied inpatient. Intervention: CIS‐(Z) ZUCLOPENTHIXOL Comparison: CIS(Z)/TRANS(E) ZUCLOPENTHIXOL (short term)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with CIS(Z)/TRANS(E) ZUCLOPENTHIXOL (short term)	Risk with CIS‐(Z) ZUCLOPENTHIXOL	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Global state: Average endpoint global state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Adverse effects: Clinically important general adverse effect	470 per 1000	630 per 1000 (385 to 1000)	RR 1.34 (0.82 to 2.18)	57 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2}	Control of risk set at moderate and rounded up from 46.4% to 47%.
Death: Suicide and natural causes (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Service outcomes: duration of stay in hospital (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Mental state: Average endpoint general mental state score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
Leaving the study early: Any reason	28 per 1000	61 per 1000 (14 to 265)	RR 2.15 (0.49 to 9.41)	140 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
General functioning: Average endpoint general functioning score (clinically improved) (no data)	not pooled	not pooled	not estimable	(0 studies)		No study reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Risk of bias: rated as 'serious' ‐ selection bias throughout. Very difficult to ascertain from published materials if selection bias has been minimised. ² Risk of imprecision: rated 'very serious' ‐ low n numbers For risks rated as serious, we downgraded by 1. For risks rated as very serious we downgraded by 2.

Summary of findings 12. Zuclopenthixol dihydrochloride (Cis Z isomer) versus Zuclopenthixol (Cis Z/Trans E isomer)

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Comparison 1. ZUCLOPENTHIXOL versus PLACEBO ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early (any reason) Show forest plot	2	100	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.01, 6.60]

2 Adverse effects: 1. Clinically important change in specific adverse effects ‐ cardiovascular ‐ orthostatic Show forest plot	1	28	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.01, 6.60]

3 Adverse effects: 2. Clinically important change in specific adverse effects ‐ central nervous system ‐ arousal state Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 excitation	1	28	Risk Ratio (M‐H, Random, 95% CI)	2.62 [0.12, 59.40]
3.2 sleepiness / sedation	1	28	Risk Ratio (M‐H, Random, 95% CI)	2.89 [1.01, 8.30]
4 Adverse effects: 3. Clinically important change in specific adverse effects ‐ endocrine ‐ menstruation started Show forest plot	1	36	Risk Ratio (M‐H, Random, 95% CI)	7.0 [0.39, 126.48]

5 Adverse effects: 4a. Any general adverse effects ‐ movement disorders ‐ EPSEs (UKU side effect rating scale, no scores) Show forest plot	1	28	Risk Ratio (M‐H, Random, 95% CI)	6.07 [0.86, 43.04]

6 Adverse effects: 4b. Clinically important change in specific adverse effects ‐ movement disorders ‐ EPSEs Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 parkinsonism	1	36	Risk Ratio (M‐H, Random, 95% CI)	5.00 [0.26, 97.37]
6.2 oculogyric crisis	1	36	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.13, 69.09]
6.3 tremor	1	36	Risk Ratio (M‐H, Random, 95% CI)	5.00 [0.26, 97.37]

Comparison 1. ZUCLOPENTHIXOL versus PLACEBO ‐ all short term

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Comparison 2. ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI, scores not reported) Show forest plot	2	135	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.75, 1.13]

2 Global state: 2. Average endpoint global state score ‐ No Recovery Show forest plot	1	64	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.89, 1.16]

3 Global state: 3a. Average endpoint global state score (GAS, high score not reported, average score = 63.4) Show forest plot	1	60	Mean Difference (IV, Random, 95% CI)	‐0.60 [‐8.12, 6.92]

4 Global state: 3b. Average endpoint global state score (CGI‐SI, high score not reported, average score = 2.2) Show forest plot	1	60	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.49, 0.49]

5 Mental state: 1. No clinically important change in general mental state ‐ Not improved (PANSS, scores not reported) Show forest plot	1	120	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.81, 1.18]

6 Mental state: 2. No clinically important change in general mental state ‐ No clinical response Show forest plot	1	64	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.25, 2.42]

7 Mental state: 3. Average endpoint general mental state score (BPRS, high score = 34.2) Show forest plot	3	221	Mean Difference (IV, Random, 95% CI)	0.40 [‐2.43, 3.23]

8 Leaving the study early (any reason) Show forest plot	6	766	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.36, 0.81]

9 Adverse effects: 1. Any general adverse effects ‐ side effects (CGI, high score not reported) Show forest plot	1	94	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.77, 0.97]

10 Adverse effects: 2. Average endpoint general adverse effect score ‐ average score (TESS, high score not reported, average score = 12.00) Show forest plot	1	60	Mean Difference (IV, Random, 95% CI)	4.48 [‐2.38, 11.34]

11 Adverse effects: 3. Any change in specific adverse effects ‐ cardiovascular ‐ postural hypotension (dizziness/syncope) Show forest plot	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 1.73]

12 Adverse effects: 4. Any change in specific adverse effects ‐ central nervous system ‐ arousal Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 excitation	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.07, 5.47]
12.2 sedation	2	163	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.73, 1.70]
13 Adverse effects: 5. Any change in specific adverse effects ‐ metabolic ‐ weight change ‐ loss or gain of weight of 10 pounds Show forest plot	1	29	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.22, 1.75]

14 Adverse effects: 6a. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs Show forest plot	3	199	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.61, 1.45]

15 Adverse effects: 6b. Any change in specific adverse effects ‐ movement disorders ‐ additional medication use Show forest plot			Other data	No numeric data

Comparison 2. ZUCLOPENTHIXOL versus CHLORPROMAZINE ‐ all short term

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Comparison 3. ZUCLOPENTHIXOL versus CHLORPROTHIXENE ‐ all medium term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Average endpoint global state score ‐ Unchanged/worse (CGI) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Leaving the study early (any reason) Show forest plot	1	20	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.34, 2.93]

Comparison 3. ZUCLOPENTHIXOL versus CHLORPROTHIXENE ‐ all medium term

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Comparison 4. ZUCLOPENTHIXOL versus CLOZAPINE ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early (any reason) Show forest plot	1	407	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

2 Adverse effects: Any general adverse effects ‐ side effects ‐ frequency per day Show forest plot			Other data	No numeric data

Comparison 4. ZUCLOPENTHIXOL versus CLOZAPINE ‐ all short term

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Comparison 5. ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Global state: 2. Average endpoint global state score (CGI, mean score = 1.25) Show forest plot	1	49	Mean Difference (IV, Random, 95% CI)	0.13 [‐0.30, 0.55]

3 Leaving the study early (any reason) Show forest plot	2	141	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.72, 1.35]

4 Adverse effects: 1. Any change in specific adverse effects ‐ interference with functioning Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5 Adverse effects: 2. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6 Adverse effects: 3. Any change in specific adverse effects ‐ requiring additional medication Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7 Adverse effects: 4. Any change in specific adverse effects ‐ requiring hypnotics/sedatives Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 5. ZUCLOPENTHIXOL versus HALOPERIDOL ‐ all short term

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Comparison 6. ZUCLOPENTHIXOL versus PERPHENAZINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Average endpoint global state score ‐ unchanged/worse (global rating ‐ investigator opinion) ‐ medium term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Leaving the study early (any reason) ‐ short/medium term Show forest plot	2	104	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.27, 1.47]

3 Adverse effects: 1. Any change in specific adverse effects ‐ central nervous system ‐ arousal ‐ requiring medication ‐ medium term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4 Adverse effects: 2. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication ‐ medium term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 6. ZUCLOPENTHIXOL versus PERPHENAZINE

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Comparison 7. ZUCLOPENTHIXOL versus RISPERIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental State: 1. Average endpoint general mental state score (PANSS, average score = 45.8) ‐ medium term Show forest plot	1	25	Mean Difference (IV, Random, 95% CI)	‐3.20 [‐7.71, 1.31]

2 Mental State: 2. Average endpoint general mental state score (PANSS General, average score medium term = 20.5) ‐ short/medium term Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 Short term	1	19	Mean Difference (IV, Random, 95% CI)	‐2.40 [‐4.52, ‐0.28]
2.2 Medium term	1	25	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐2.72, 2.12]
3 Mental State: 3. Average endpoint general mental state score (PANSS Positive, average score = 9.8) ‐ medium term Show forest plot	1	25	Mean Difference (IV, Random, 95% CI)	‐1.0 [‐2.69, 0.69]

4 Mental State: 4. Average endpoint general mental state score (PANSS Negative, average score 11.5) ‐ medium term Show forest plot	1	25	Mean Difference (IV, Random, 95% CI)	‐1.5 [‐4.05, 1.05]

5 Leaving the study early (any reason) ‐ short/medium term Show forest plot	3	154	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.84, 2.02]

6 Adverse Effects: 1. Any change in general adverse effects ‐ additional medication use ‐ short/medium term Show forest plot			Other data	No numeric data

7 Adverse effects: 2a. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs ‐ requiring medication ‐ short term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8 Adverse Effects: 2b. Any change in specific adverse effects ‐ movement disorders ‐ EPSEs (ESRS) ‐ short term Show forest plot	1	19	Mean Difference (IV, Random, 95% CI)	4.5 [0.67, 8.33]

9 Adverse effects: 3. Any change in specific adverse effects ‐ negative and cognitive symptoms of schizophrenia ‐ short term Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 UKU ‐ asthenia/lassitude/increased fatiguability	1	98	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.67, 1.01]

Comparison 7. ZUCLOPENTHIXOL versus RISPERIDONE

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Comparison 8. ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Average endpoint global state score ‐ Unchanged/worse (CGI) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Global State: 2. Average endpoint global state score ‐ Moderately or severely ill (CGI) Show forest plot	1	61	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.75, 1.30]

3 Mental State: Average endpoint general mental state score (BPRS, average = 5.7) Show forest plot	1	61	Mean Difference (IV, Random, 95% CI)	‐1.30 [‐5.08, 2.48]

4 Leaving the study early (any reason) Show forest plot	1	61	Risk Ratio (M‐H, Random, 95% CI)	2.07 [0.97, 4.40]

5 Adverse Effects: 1. Any change in general adverse effects ‐ additional medication use Show forest plot			Other data	No numeric data

6 Adverse Effects: 2. Any change in specific adverse effects ‐ metabolic ‐ weight change Show forest plot	1	61	Mean Difference (IV, Random, 95% CI)	‐1.60 [‐8.35, 5.15]

7 Adverse effects: 3. Any change in specific adverse effects ‐ requiring additional medication ‐ hypnotics/sedatives Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 8. ZUCLOPENTHIXOL versus SULPIRIDE ‐ all short term

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Comparison 9. ZUCLOPENTHIXOL versus THIOTHIXENE ‐ all medium term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Average endpoint global state score ‐ unchanged/worse (CGI) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Leaving the study early (any reason) Show forest plot	1	20	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.24, 1.35]

Comparison 9. ZUCLOPENTHIXOL versus THIOTHIXENE ‐ all medium term

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Comparison 10. ZUCLOPENTHIXOL versus TRIFLUOPERAZINE ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early (any reason) Show forest plot	1	72	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 10. ZUCLOPENTHIXOL versus TRIFLUOPERAZINE ‐ all short term

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Comparison 11. ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early (any reason) Show forest plot	1	46	Risk Ratio (M‐H, Random, 95% CI)	1.95 [0.36, 10.58]

2 Behaviour: Average change in specific aspects of behaviour ‐ Violence during follow‐up Show forest plot	1	46	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.44, 1.71]

3 Adverse Effects: 1a. Any general adverse effects ‐ additional medication use Show forest plot			Other data	No numeric data

4 Adverse Effects: 1b. Any change in specific adverse effects ‐ additional medication use ‐ benzodiazepine use at least once Show forest plot	1	46	Risk Ratio (M‐H, Random, 95% CI)	1.3 [0.59, 2.86]

Comparison 11. ZUCLOPENTHIXOL versus ZUCLOPENTHIXOL DEPOT ‐ all long term

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Comparison 12. CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Average endpoint global state score ‐ Unwell Show forest plot	3	131	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.80, 1.17]

2 Mental state: Average endpoint general mental state score ‐ Not improved Show forest plot	1	57	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.45, 2.07]

3 Leaving the study early (any reason) Show forest plot	4	140	Risk Ratio (M‐H, Random, 95% CI)	2.15 [0.49, 9.41]

4 Adverse Effects: 1a. Any general adverse effects ‐ side effects reported Show forest plot	1	57	Risk Ratio (M‐H, Random, 95% CI)	1.34 [0.82, 2.18]

5 Adverse Effects: 1b. Any change in specific adverse effects ‐ individual side effects Show forest plot			Other data	No numeric data

Comparison 12. CIS‐(Z) ZUCLOPENTHIXOL versus CIS(Z)/TRANS(E) ZUCLOPENTHIXOL ‐ all short term

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